UMIN-CTR Clinical Trial

Basic information
Public title	Cardiovascular prognostic coupling study in Japan
Acronym	Cardiovascular prognostic coupling study in Japan(Coupling Registry)
Scientific Title	Cardiovascular prognostic coupling study in Japan
Scientific Title:Acronym	Cardiovascular prognostic coupling study in Japan(Coupling Registry)
Region	Japan

Condition
Condition	Cardiovascular disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to clarify the relationship between the blood pressure variability and vascular properties in hypertensive, and to investigate its relationships with the onset of cardiovascular events in patients at high risk of cardiovascular disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time to major cardiovascular events*. *Major cardiovascular events; a composite of cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, unknown type of stroke, myocardial infarction, cardiovascular intervention due to angina pectoris, and sudden death.
Key secondary outcomes	1. Time to various events onset*. * In addition to each component of major cardiovascular events, followings are considered as "various events": hospitalization by angina pectoris; hospitalization by heart failure, aortic dissection; occlusive arteriosclerosis; end stage renal insufficiency; doubling of serum creatinine values; new onset of atrial fibrillation; dementia; need of nursing care; total death. 2. Change in blood pressure 3. Increase of CAVI or ABI value. 4. Development of left ventricular hypertrophy 5. Adverse event

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient with at least one of the following cardiovascular risk factor: 1. Diabetes, glucose tolerance disorder 2. Dyslipidemia 3. high-normal normotension and grade I - III hypertension (>130/85 mmHg) 4. Current smoking 5. Renal disease (eGFR <= 60 or positive proteinuria) 6. Past history of cardiovascular disease (coronary artery disease, cerebrovascular disorder or non-cardiogenic cerebrovascular disorder, aortic dissection, peripheral artery disease, history of hospitalization by heart failure) 7. atrial fibrillation 8. Metabolic syndrome 9. Chronic obstructive pulmonary disease 10. Sleep apnea syndrome
Key exclusion criteria	1. Patients with chronic renal failure in haemodialysis 2. Other seriously ill patients (e.g. end stage of cancer, active connective tissue disease) 3. Alcohol addiction 4. Drug addiction 5. Patients who cannot visit a hospital alone by walk 6. Patients who cannot give informed consent by themselves 7. Patients who are judged to be inappropriate for the study by physician
Target sample size	7000

Research contact person
Name of lead principal investigator	1st name Kazuomi Middle name Last name Kario
Organization	Jichi Medical University School of Medicine
Division name	Division of Cardiovascular Medicine, Department of Medicine
Zip code	329-0498
Address	3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498,Japan.
TEL	0285-58-7344
Email	kkario@jichi.ac.jp

Public contact
Name of contact person	1st name Kazuomi Middle name Last name Kario
Organization	Jichi Medical University School of
Division name	Division of Cardiovascular Medicine, Department of Medicine
Zip code	329-0498
Address	3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498,Japan.
TEL	0285-58-7344
Homepage URL
Email	coupling@jichi.ac.jp

Sponsor
Institute	Jichi Medical University School of Medicine
Institute
Department

Funding Source
Organization	Community Medicine Cardiovascular Research Asia IT Network Center, Division of Cardiovascular Medicine Jichi Medical University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	FUKUDA DENSHI CO.,LTD.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Jichi Medical School clinical study support center
Address	3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan.
Tel	0285-58-8933
Email	rinri@jichi.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions

Institutions

鷲谷病院（栃木県）、フクダ電子株式会社（東京都）、今別町国民健康保険今別診療所（青森県）、 沖縄県立中部病院（沖縄県）、遠賀中間医師会おんが病院（福岡県）、かわしま循環器内科（栃木県）、 久保田クリニック（東京都）、小竹町立病院（福岡県）、東吾妻町国民健康保険診療所（群馬県）、 藤田脳神経外科医院（香川県）、南三陸病院（宮城県）、山際クリニック（愛知県）、 周防大島町立東和病院（山口県）、岩国市医療センター医師会病院（山口県）、 まつい内科クリニック（山口県）、石橋内科医院（茨城県）、阿部内科医院（兵庫県）、 佐久総合病院佐久医療センター（長野県）、南和歌山医療センター（和歌山県）、表参道内科眼科（東京都）、 JCHOうつのみや病院（栃木県）、富士通クリニック（神奈川県）、 馬渡島診療所（佐賀県）、八代市椎原診療所（熊本県）、国民健康保険大間病院（青森県）、 大島診療所（福岡県）、国際医療福祉大学病院（栃木県）、結城病院（茨城県）、新小山市民病院（栃木県）、 とちぎメディカルセンターしもつが（栃木県）

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 29 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	6068
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 03 Month 26 Day
Date of IRB	2015 Year 03 Month 26 Day
Anticipated trial start date	2015 Year 07 Month 29 Day
Last follow-up date	2027 Year 10 Month 31 Day
Date of closure to data entry	2028 Year 01 Month 31 Day
Date trial data considered complete	2028 Year 03 Month 31 Day
Date analysis concluded	2029 Year 03 Month 31 Day

Other
Other related information	This is a prospective cohort study. Follow up period: Seven years. Patients are followed up regularly for seven years every one year from a registration day.

Management information
Registered date	2015 Year 07 Month 29 Day
Last modified on	2019 Year 08 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021342